510(k) K191565 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Endoskeleton TCS Interbody Fusion Device
| Applicant | Titan Spine, Inc., Mequon WI, US |
| Decision | Substantially Equivalent, Aug 6, 2019 |
| Received | Jun 13, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191565
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.